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Nearly 60 years after scientists tried and disastrously failed to develop a vaccine for respiratory syncytial virus (RSV), the Food and Drug Administration has approved the first-ever RSV shot.
On Wednesday, the FDA gave a thumbs-up to Arexvy, the RSV vaccine developed by British pharmaceutical company GSK, which is intended for those 60 years old and up. The vaccine is a single shot and could be available for seniors as soon as the fall, CNN reported.
“Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
RSV attacks the lungs and breathing passages, and can cause pneumonia and bronchitis in older adults, according to the FDA. The Centers for Disease Control and Prevention estimates that up to 10,000 people aged 65 and older in the U.S. die after contracting RSV each year.
“Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,” Marks said.
RSV also poses a higher risk to infants with between 100-300 babies dying in the U.S. from the virus each year. Along with the new RSV shot for older adults, the FDA is also currently considering granting approval to a first-of-its-kind Pfizer vaccine that is administered to expectant mothers during the second half of their pregnancy to protect infants against RSV.
According to the late-stage trial data, Pfizer’s experimental vaccine was 82% effective in preventing severe cases of the potentially deadly virus in infants 90 days after birth, but that dropped to 69% efficacy in preventing severe infections up to 180 days after a baby is born. The Pfizer shot also failed to meet its second goal of reducing non-severe illness in newborns, Reuters reported.
The FDA’s approval of the GSK vaccine comes after nearly six decades of attempts at developing a shot for RSV.
The first try at producing an RSV vaccine in the late 1960s ended in disaster when two children died and many were hospitalized with severe RSV after taking the experimental vaccines, according to CNN. During the trial, 80% of the vaccinated children were hospitalized compared to only 5% who got the placebo. The tragedy forced researchers to put a pause on developing an RSV vaccine.
After eight years of study, researchers at Johns Hopkins University revealed findings in 2008 that showed the late 1960s RSV vaccine trial failed because children’s antibodies were not binding to the inactivated virus strongly enough, Reuters reported. The antibodies, instead, were pulling the dead virus with them, causing the immune system to respond with a massive attack.
Now, scientists have high hopes for the rollout of RSV vaccines. An international study on the GSK vaccine looked at 25,000 people 65 and older and found that one dose of the vaccine was nearly 83% effective at preventing lung infections that stem from RSV, the Associated Press reported. The trial data also showed that the risk of severe infections was reduced by 94%.
Pfizer also has a vaccine for older adults similar to Arexvy that the FDA is currently considering approval for.